Exogen Biotechnology, a Berkeley, Calif.–based tech start-up, wants more than people’s money to fund its genetic research—it also wants their DNA. But the company doesn’t sequence people’s genomes, like 23andMe does. Rather, it measures the overall health of people’s genomes by counting double-strand breaks in their DNA.
Exogen’s research project is one of the latest entrants into the burgeoning field of crowdfunded “citizen science.” It sells a DNA damage testing kit to consumers who send back a blood sample for analysis. To count the double-strand breaks, the company uses an automated technology that co-founder Sylvain Costes developed at Lawrence Berkeley National Laboratory, which supplants the traditional, painstaking process of counting breaks by hand.
As the company Web site explains, everyone has DNA damage due to aging, lifestyle and environmental exposures, which the body will often repair. But some people may have a higher risk of damage if, for example, they’re elderly smokers who like to tan on the beach. Furthermore, two people with seemingly similar risk levels may differ because individuals vary in their natural ability to repair DNA. This means some individuals may have accrued more damage than others. Based on the DNA analysis and demographic information they collect along with the test, Exogen says it can tell people where they sit on the risk continuum compared with others of similar age, lifestyle, geographic location and other factors.
Costes and co-founder Jonathan Tang ultimately want to create a worldwide database with this information (although customers can opt out if they choose). They think it will inform our understanding of how health problems such as premature aging, cancer and other diseases are linked to DNA damage caused by lifestyle and environmental factors such as smoking and exposure to ionizing radiation.
Because Exogen uses a rather avant-garde method for its research, as do other citizen science projects, its approach raises a fundamental question: Is it promising its customers more than its test can actually tell them about their health?
Higher DNA damage may increase the risk of certain health problems, such as cancer, but scientists do not know enough yet to draw a direct causal line or reliable correlation. “Whether this test result will give the individual knowledge of how to behave or what to expect in life, we don’t have the slightest idea about that at the moment,” says Lawrence Loeb, a DNA mutation expert at the University of Washington. And although it can’t hurt if test results push someone to exercise more, smoke less or wear sunscreen, it should not give individuals with lower than average DNA damage the idea that they are bulletproof, according to Loeb.
Exogen believes it has made the limitations of its test clear to people buying its kits. It is targeting “quantified selfers,” people who are eager to understand more about their own genetics. The test does not tell them much about their personal health for now, but Exogen’s owners hope that will change. They want to gather enough data from their customers to be able to spot links between DNA damage, environmental and lifestyle factors, and disease. “It doesn’t necessarily mean that if your DNA damage is high, you’re going to get cancer,” says Steve Yannone, the Principle Scientist at Exogen and researcher at Lawrence Berkeley. “That’s where the research comes in. We’re trying to push towards getting those types of correlations.”
The company hopes to eventually run its research results through the peer review process, just like a traditional study, and publish its findings in a scientific journal. If the DNA damage test turns out to be diagnostically useful, it plans to sell the technology to medical professionals rather than the public.
Although Exogen’s owners acknowledge the lack of evidence linking DNA damage to disease, its marketing approach is somewhat less forthcoming. Its Web site does not clearly indicate that scientists have not established dependable correlations between DNA damage and disease in most people (exceptions include certain rare hereditary diseases). Instead, their site states, “It is important to minimize damage to your DNA because scientists have linked DNA damage and poor repair to cancer, neurological diseases, accelerated aging and many other serious medical conditions,” which the average consumer might assume means a definitive link. “Their Web site is a little bit leaning towards hype,” says Scott Diehl, director of the Center for Pharmacogenomics and Complex Disease Research at Rutgers University. Yet Diehl also concedes that in order to crowdfund a project, you can’t be shy. “These guys are pretty good. They’re asking people to support their research—yes, they’re also quasi selling them a test, but it’s pretty mild compared to the other charlatans out there.”
Some scientists are also skeptical of Exogen’s unusual study methods because, like other citizen science projects, the company gathers data from customers rather than using a standardized clinical trial study setup. Yannone defended the company’s credentials, however. “We’re not a bunch of vegetable farmers, we’re scientists, so we know how this works,” he says. “We expect our study methods to stand up in the peer review process.”
As with any business that analyzes people’s genetic material, privacy questions inevitably arise. Exogen’s privacy policy seems standard, according to Diehl, and users own their data and decide whether they want to participate in Exogen’s research. Users can also opt to remove all personal information from the database if they wish. If Exogen publishes its study, participants remain anonymous.
There’s also the danger that companies could intentionally or accidentally leak personal genomic information to others who find it valuable, such as insurance companies, employers and advertisers. The 2008 Genetic Information Nondiscrimination Act has mitigated this danger to some extent. It prohibits health insurance companies and employers from discriminating based on DNA, such as denying health coverage or employment, respectively, to individuals because they have a genetic predisposition for a particular disease.
Yet privacy concerns about Exogen seem pretty minor compared with other genetic sequencing businesses, at least so far. The information Exogen deals with is not as valuable as a complete genetic profile because scientists, much less advertisers and insurance companies, do not yet understand what DNA damage says about personal health, although this may change if Exogen is successful.
Exogen’s owners think that someday a DNA damage test may be as commonplace as a cholesterol test and that it will help doctors evaluate the risk of certain diseases. And because people vary in their ability to repair their DNA, it may also tell someone whether they’re more or less at risk for some diseases when they engage in genetically damaging activities, such as smoking or baking on a sunny beach. It could also pinpoint whether a toxic exposure event, such as the recent chemical spill in Charleston, W.Va., can damage people’s DNA in a way that causes serious health problems.
With over $80,000 raised from crowdfunding it’s obvious that many people are excited by Exogen’s research. It is not as apparent that they realize their contributions—both monetary and fluid—are mostly altruistic for now.